Clinical Research

Episode Transcript

SPEAKERS

Mark Young, Justin Girouard

 

Mark Young  00:18

Welcome, everybody to another edition of CPG insiders. I'm your host Mark Young with my co host, and colleague, Justin Girouard.

 

Justin Girouard  00:28

Here to save the day.

 

Mark Young  00:30

There you go, Justin, we're going to have a little discussion today won't be a long show, we're going to have a little talk today about something that that we talk to clients about. And, and I've said this before, but I'm going to just repeat this for people these shows are essentially conversations that we have every week. So where the where the core of the show sometimes comes from is we just had this conversation with three clients in the past week and it's like, you know what, three people have asked the same question. So let's go lay it down as a podcast. Because if three people asked it this week, then there's got to be other people that are asking it to themselves this week. And that's where the shows come from. So no, no big mysterious planning. We don't sit around in a room and plot out shows. It's like, what are people been asking us this month?

 

Justin Girouard  01:18

Yeah. So on that note, again, always feel free to email us if you're a listener, and you have any questions or topics you want to talk about. Because that's that's a lot of where this comes from. And you're not the only one who has the question that you have.

 

Mark Young  01:31

Yeah, so so essentially, every show is built on something that someone asked.

 

Justin Girouard  01:36

Yeah

 

Mark Young  01:37

So we get asked a lot about running clinical trials and research.

 

Justin Girouard  01:43

Yeah.

 

Mark Young  01:44

So I thought we'd have a discussion about it. Now, I want people to understand we are not giving you medical advice, we are not giving you clinical advice. We are holding a discussion, as if we were talking to you as a client today.

 

Justin Girouard  01:57

Absolutely. where we're coming from strictly from an advertising or marketing perspective on the value and possible ways to go about it. That's, that's that's exactly what we're going to be doing.

 

Mark Young  02:09

So I recently had one of the conversations that just happened this week was a client that came to me in so we'd like to have have a product that does X. Is it even in clinical trials? No, but we have two ingredients that have had clinical trials. And that sometimes works, and we'll discuss that in a minute. And then I said, well do the two clinical trials that you have for your ingredients. Were the clinical trials run based upon the claim you want to make? And the answer was no. So first, let's start with why do we want to have a clinical trial. So there there is what we'll call first party and there is third party. First party means you, your company, your organization ran a clinical trial on your formula on your product, or your item or your device. Third party clinical trials means that someone else likely a university or a drug company or something has run a clinical trial on an ingredient that you have in your formula. So as an example, let's say that I wanted to, I was going to put out a new brand of aspirin. There's a million clinical trials around about aspirin. If I make an aspirin with the same ingredients as those other clinical trials, in the same dosage as those clinical trials, and I advise consumers that my instructions for use are the same as those clinical trials. Then, yes, I can use that third party research to make claims against. But if I change anything, then I can't make direct comparisons.

 

Justin Girouard  04:07

Yep.

 

Mark Young  04:07

So let's say that I was making a supplement. And my new supplement has five things in it. So I put Kava Kava and melatonin and magnesium and you know, five HTP and L theanine and I dumped them all into one capsule, and I called it my new sleep pill.

 

Justin Girouard  04:31

Right.

 

Mark Young  04:33

All of those ingredients do have clinical trials. They don't have clinical trials combined. So the most that you could say is the ingredients in Super sleep aid have been shown to do X. You can't say that super sleep aid does X but you can say the ingredients in it have been shown to do X.

 

Justin Girouard  05:01

You can make claims like clinically studied ingredients.

 

Mark Young  05:05

Right, now if I run a clinical trial on Super sleep X, I could now say, in a clinical trial 74% of people taking sleep super sleep X fell asleep 70% sooner if that, indeed was the outcome. So these are the differences. This is difference between third party and first party. Now, the second thing is, what kind of clinical trials are out there. While there are clinical trials or drug clinical trials, there are observational clinical trials or biologic clinical trials. It depends how complicated you want this clinical trial to be how much money you want to spend on it, and what you're trying to discover. So let's say that you have come up with a formula that you think will help people lose weight. You could run a double blind clinical trial, which means half of your participants get a placebo and half get the real product. And the people conducting the trial do not know the difference. They don't know who the participants are as far as who has the real drug. And then you could say, participants in a clinical trial taking diet pill X lost, you know, 52% more weight than those in the placebo group. You know, again, assuming that is the outcome right? Now, one of the things people get confused about is the size of a clinical trial.

 

Justin Girouard  06:45

Oh, yeah, absolutely. We get to that all the time. They think they have to be massive. But

 

Mark Young  06:51

And they really don't.

 

Justin Girouard  06:52

they really don't. They really don't. You don't have to have a 600 person clinical trial? No, not at all.

 

Mark Young  07:01

So let's say I was doing that diet study. I could do that diet study with 20 participants, and 10 have my real pill and 10 don't. So what you have to be careful of, you don't need to have hundreds and hundreds of people in your trial. But you need to have enough people in your trial where the law of small numbers won't ruin your outcome. So as an example, let's say I did a clinical trial, and I only put in five people on the drug and five people on the placebo, will have just two people had something going on in their biology that made my product not work. My trial is gonna look like it failed. Where all I did was I got caught by the law of randomness that I happened to hook two people with a certain gene sequence. Where has had I had 10 People in the trial, right, I still would have only had two people with that gene sequence, which just reduce their impact to 20%. From 40%.

 

Justin Girouard  08:07

Right, exactly.

 

Mark Young  08:09

So your trial needs to be big enough to rule out randomness and to rule out the laws of small numbers. But it doesn't have to be enormous. And I'll give you example, Justin and I were doing some polling yesterday on Twitter. And those two polls that we did on Twitter, Justin ended up with 800, and some votes each.

 

Justin Girouard  08:34

Those are really stable numbers.

 

Mark Young  08:36

But the reality is they didn't change by more than a few percentage points. Once we crossed the number of about 75 or 100 participants.

 

Justin Girouard  08:47

Right.

 

Mark Young  08:49

 Nothing moved by more than two points after that. Right. So the fact that 800 votes, lets us know that that's a real size pool. That's a sizable pool of people that voted. And it's big enough to take the law of randomness out. But by time we got to 100. We knew the outcome.

 

Justin Girouard  09:10

Yeah, so we didn't require that 800 number to really understand the outcome of the study, or the poll that matter.

 

Mark Young  09:18

Right. But it was it but it was good. So when we do these different clinical trials, there are clinical trials that we refer to as observation.

 

Justin Girouard  09:28

 Yes.

 

Mark Young  09:30

Observational means I'm going to bring in 20 participants, I'm going to have them fill out a questionnaire. I'm going to give them my device, I'm going to give them my pill, or whatever it is. I'm going to send them home with a logbook. And I'm going to ask them to take this on the certain time of day every day and I'm going to ask them to write down answer the following questions. You know, do I feel hungry? Do I feel energetic? Am I feeling any nervousness, whatever the case is, I'm going to give me Questions want to ask them to fill these logs out? If it's a weight loss, I'm going to take their weight.

 

Justin Girouard  10:05

Right.

 

Mark Young  10:07

And then I'm going to set up an algorithm. And I'm going to ask those people to probably come back into my clinic every two weeks for the next 12 weeks, when it comes back in in two weeks, I'm going to interview them, I'm going to collect their logs. If it's a diet pill, I'm gonna weigh them, if it's blood pressure, I'm going to take their blood pressure,

 

Justin Girouard  10:25

Right

 

Mark Young  10:26

whatever the case is. These are observational, we're not doing anything to invade their body. We're not taking blood tests, we're not doing anything that requires a doctor, we're not doing anything that requires a nurse practitioner. We're observing their behavior.

 

Justin Girouard  10:45

Exactly. And when you think about most products, right, and again, as you talked about earlier, it all depends on what are the desired outcomes that you're looking for. Right. But most products, because when we're talking about clinical studies, again, what's the main reason? I want to be able to say what my product does. Right? That's always what it comes down to? Is I formulated it does this, but there are some governing bodies that say, well, we're not going to let you say that in advertising and marketing. So great. I want to say what it does. And so most products, you can conduct an observational study, to get the claims that you're looking for. So as we talked about, you always want to ensure that when you're starting this, start with the why. Anytime you're thinking about going into this endeavor, understand, hey, what is it that I'm really trying to figure out? What is it I'm really trying to say? And that's also something Mark, we talk to a lot about too, even when we've had clients in the past. Yeah, I've run a clinical look at them and say, okay, but you didn't structure your clinical to figure out exactly what you wanted, because you didn't understand what you wanted to say yet .So you really want...

 

Mark Young  11:54

What is the question I am trying to answer?

 

Justin Girouard  11:57

Exactly. And again, down to is most of the time observational study will get the job done. And it's it's a lot less complex, and frankly, usually cost a lot less too.

 

Mark Young  12:09

Right. Now, if we start getting into medical studies, let's say we want to say that our product lowers A1C.

 

Justin Girouard  12:15

Right.

 

Mark Young  12:17

And lower A1C, we're going to have to take people's A1C, or we're going to have to take their glucose levels. So now the complexity of our clinical trial is ratcheting up. Now, we might need a nurse practitioner to do the interviews rather than a PhD or PhD candidate. Who can who can do the clinical trials. By the way, folks, most clinical trials are not done by doctors of medicine, they're done by doctors of PhD level.

 

Justin Girouard  12:48

Research. Yeah, yeah.

 

Mark Young  12:50

Right. Because running a clinical trial is less about knowing medicine, and more about understanding the algorithms and the methodologies behind research and the way to properly write the document.

 

Justin Girouard  13:05

 Exactly.

 

Mark Young  13:06

And who writes the document is everything. Also, keep in mind that all these clinical trials that we're talking about, this does not mean you go do this yourself. You are running this yourself, this is not an independent clinical trial, you have a vested interest in this. So you do need to hire a third party to come in and do this. And there are, there are doctors you can hire. There are independent PhDs you can hire, there are CRO's that you can hire, which are called clinical research organizations. There are universities that will run clinical trials for you. Now, the big question I always get is how much does a clinical trial cost? It's always going depend on the complexity. I usually tell people to anticipate at least 2000 to $2,500 per participant for a simple observational clinical trial. And you can easily spend 10 20 $30,000 per participant if you're going to do a medical clinical trial. Right. But even at 2500, which is not unreasonable. A 25 per 20 person trials $50,000.

 

Justin Girouard  14:27

Right.

 

Mark Young  14:28

I find most of these are between 50 and 100. 50 and 75 is probably the sweet spot. Yeah, I've seen some 40s out there. So I'm gonna say 40 to 75 is probably the sweet spot. I've seen a few simple observation ones that got done for like 15 $1,800 a person if it was easy.

 

Justin Girouard  14:49

Yeah. Yeah, if they're simple.

 

Mark Young  14:52

It depends how many weeks it goes for and how many times they need to interview the participants. Now I want you to understand something else a clinical trial. does not replace a monograph. So let's talk about the difference between a clinical trial and a monograph.

 

Justin Girouard  15:08

So when we're talking about clinical trials, right? When we talk about marketing and advertising, what that means is as as Mark stated, when we're making a claim, it comes with the qualifier of whatever it is. And that's the only claim you can make. So it's based on the study the exact results that came in. So even when Mark is talking about things like the observational studies, right, we can say things like participants observed, or participants said that 62% of participants felt more energy, right? In a clinical trial, we can say claims like that, now..

 

Mark Young  15:45

Which would be different than saying this drug increases mitochondria output.

 

Justin Girouard  15:52

Right. Exactly. When you're talking about a monograph, that means that the ingredient has been studied through the FDA, which I mean, those go 1 billion average?

 

Mark Young  16:04

Average of a couple of billion average of a couple of billion.

 

Justin Girouard  16:07

Exactly. And so then that means that great it's gone through and created a monograph through the FDA, a couple billion dollars, and now registered with the FDA, you can make these claims against disease states, now you officially can do these types of things. So you can say things against arthritis, or you can say things against diabetes, or any anything of that nature, they will allow you to say that great, you are able to say that your product does, you know, reduce pain for arthritis or anything of that nature. Now, that's going against a direct disease state in the clinical trials, as Mark is talking about really what we're really talking about is is is almost marker claims, right? To say that you lower the A1C is different than saying you can treat diabetes, these are not the same thing. Right? Or the fact that you're in a in a clinical trial, it showed to reduce inflammation. Okay, in a clinical trial, you can say that it was able to reduce inflammation, or people reported that kind of thing, right? But again, you got to be careful because you can't talk against directly disease states. Those are monographs. Right. So inflammation might be that our clinical trial observed that wrapping a tape measure around a kneeRight.

 

Mark Young  17:28

before and after applying your topical pain, reduce the circumference of the knee by half an inch.

 

Justin Girouard  17:34

Right.

 

Mark Young  17:35

That does not mean that this is a cure for systemic inflammation.

 

Justin Girouard  17:40

Right.

 

Mark Young  17:40

It means that you observe this, let me give you another example. We see these a lot anti aging claims. So buy new face cream gets rid of wrinkles. No, your new face cream may reduce the appearance of fine lines and wrinkles.

 

Justin Girouard  18:00

Right.

 

Mark Young  18:01

We cannot make a medical claim that it actually gets rid of wrinkles unless we have a monograph because that's a drug claim.

 

Justin Girouard  18:09

Exactly.

 

Mark Young  18:10

To say that your drug is anti aging means you need a monograph that says it is capable of reversing the age of DNA. That's a big ask.

 

Justin Girouard  18:21

And I think this there's a subtle word that you're slotting into this conversation is drug, right? And the biggest differentiator so if you're getting a monograph, you officially have a drug with the FDA.

 

Mark Young  18:37

So you have to avoid making drug like claims.

 

Justin Girouard  18:41

Which according to the FDA means what?

 

Mark Young  18:43

That you this is a disease state and easy way to look at it as does a doctor have a billing code for it.

 

Justin Girouard  18:51

There you go.

 

Mark Young  18:52

If a doctor can see you for it, then it's a disease state. So a doctor could easily see you for the for the condition called anxiety. That's a disease state. For you to say that taking my new supplement with L theanine will reduce anxiety is a no. You can't say that. To say that, in a clinical trial, 72% of participants reported less feelings of anxiousness.

 

Justin Girouard  19:29

Right.

 

Mark Young  19:31

That's fair to say that they reported less anxiety, no, because that's a diagnosis. Stay away from diagnosis, and talk in more general terms. Well, I'll give you an example. Toenail fungus. According to the FDA, the only way to treat toenail fungus is with an oral medication. But we know that there are several good topical products on the market that you can use and we handle one of them. That's a great product and you can use it topically in about four weeks, it'll start clearing up toenail fungus. But we can't say that. So we have to dance around it. We have to say, you know, toe fungus, not toenail fungus, we have to say, you know, treat ugly toenails.

 

Justin Girouard  20:27

Right.

 

Mark Young  20:28

Because ugly toenails isn't a disease state. In fact, for this particular client, we invented a disease last year that we called Winter toe.

 

Justin Girouard  20:39

Yep.

 

Mark Young  20:40

And we've had had a tremendous sales success with it. And we were the cure for winter toe because we can be the cure for a disease if we invent the disease.

 

Justin Girouard  20:50

Right. It doesn't actually exist, or to the FDA. We're not breaking any rules here.

 

Mark Young  20:57

Right. So I can't go to the doctor and say, Doc, I've got a case of winter toe, what can you give me the doc says, Hey, I don't know, we don't we don't have a billing code for winter toe.

 

Justin Girouard  21:07

Right.

 

Mark Young  21:07

Let me look at your toe. Now he might come back and say you have toenail fungus. But but he doesn't have something called Winter toe.

 

Justin Girouard  21:17

Mm hmm.

 

Mark Young  21:19

Now our description of winter toe we created a description for it. And our description was that we believe winter toe is what happens when you live in a cold damp climate and you wear boots and you are out in the snow in the rain and your feet get damp and moist. Then it creates an environment where toenail fungus can develop. That's our description of winter toe not an unreasonable description. And a fairly legitimate cause and effect.

 

Justin Girouard  21:50

Absolutely. Like you said, we're not saying winter toe is toenail fungus. That's not what we're saying.

 

Mark Young  21:57

We actually never said winter toe was anything.

 

Justin Girouard  21:59

Exactly. The point.

 

Mark Young  22:02

It sounded horrible.

 

Justin Girouard  22:04

 it did. Yeah.

 

Mark Young  22:06

Winter toe. I don't want winter toe

 

Justin Girouard  22:09

No.

 

Mark Young  22:10

That sounds gnarly.

 

Justin Girouard  22:12

Graphics showing this damp and moist eww gross. There you go. Yeah, nobody wants that.

 

Mark Young  22:17

You've got winter toe. This this. This was actually Okay, who invented this. Originally, it was back in the P&G days with whisk with ring around the collar. And this was a campaign when I was a child. And I mean, they were black and white. And you'd see this woman she was all focused on being a great homemaker. And she'd be ironing a shirt another woman whispers to another woman, he's got ring around the collar. And this woman would be horrified because that meant she was a horrible homemaker because she didn't get the ring around the collar out of her husband's shirt. So you took whisk, and you just put it right on the collar and stuck it in the washing machine. And they got rid of this little black ring that was around your shirt collar.

 

Justin Girouard  22:32

Yeah, they created an indication.

 

Mark Young  23:09

Yep, they created a problem. And then they created the solution all at once.

 

Justin Girouard  23:14

Yep. Yep.

 

Mark Young  23:16

But at any rate, and that was safe, because there's no disease state invovled.

 

Justin Girouard  23:20

Right. Right. But as you stated, right, the, again, getting back to the concept, there are many different ways to to, to conduct clinical research, there's many different types, there's, there's different costs involved, as you stated, there's different people that you can reach out to, to help get this conducted, there are many, many resources if you want to go this route. Again..

 

Mark Young  23:45

Yeah, you get a lot of universities and participate in these if you can, if you know a professor that's in a category, if you can find a professor that's in a category who is working with, uh, you know, with graduate students, not not undergrad.

 

Justin Girouard  23:59

Right.

 

Mark Young  24:00

But if you can get a professor to make this a class project, right? We're a grad class. Yep. A lot of trials get done like that.

 

Justin Girouard  24:10

Absolutely. And, again, for any listeners, we have a lot of contacts in this space. So if you are interested, please feel free to reach out. We do have contacts in different roles we can help you in this in this process. So the one question I would have for you then Mark, again, as we're talking about clinicals. So if, if we've got to listen to right now saying, You know what? I'm thinking this is what I should do. What would you say is great, here are the steps to take for this process. What would be that, you know, maybe your steps one through five of our if you're going to do this, here's what you're gonna want to make sure that you do.

 

Mark Young  24:51

Well, the first thing keep in mind is clinical trials aren't aren't usually run in an effort to find the result they're run to some substantiate an answer. So step one, what is the claim that you are trying to make? Two, have you validated as much as you can, that you can make that claim that your product is doing is have you given it to friends and family? Have you done if you looked at all the third party research, have you done is if you've gone as far as you can go, to be relatively confident that my diet pill will help reduce hunger pains. Right, let's say that's what we're after. Okay, so you got there.

 

Justin Girouard  25:36

Right

 

Mark Young  25:36

Now? What type of clinical trial do I need? So, do I need to do a clinical trial, that is observational? Can I get away with that? Or do I need to have medical personnel involved?

 

Justin Girouard  25:53

Yep.

 

Mark Young  25:55

So now I've decided that now, who am I going to hire to do the trial? Because I'm not going to do it in house? Am I going to use a CRO? Am I going to get online and look for an independent PhD? Am I going to go to a university professor and see if I can get a graduate class to do it? Once you've gotten your your, what we call principal researcher on board, that's the person that's in charge of the of the research and the person who's going to write the conclusion. How many people do I need? How long is the trial going to be going for? Let's design my trial. Now that's done. Now let's go find our trial participants. If you're using a CRO they know how to find the participants, if you're using an independent, you might have to help them with some digital advertising. Maybe you run a Facebook campaign, it says we're looking for 20 volunteers who are interested in reducing the appearance of fine lines. And you get people you know, and we're going to let you participate for free and we're going to give you a free product and whatever the case is, gets participants, hand them off to your clinical researcher, your principal researcher, step away from the bench. Now get your nose out from under the tent and let that person conduct this without your interaction. Now, let him go do this. And here's the reason you want to do that. Because should the FDA the FTC ever come in and decide we want to challenge your clinical trial, you want to have a clean file that shows the protocols that was taken to ensure that no one tilted the scale that no one had to thumb on the scale. And you want to have a principal investigator who has a track record of integrity. Who is going to say no, I conducted this trial. And this is the methodology I used and the company did not have any undue influence and did not try to put a thumb on the scale and they did not try to persuade me to go in any particular direction. You will persuade them to go in a particular direction by virtue of the fact that you've already done the initial homework and you've decided the question you want to answer.

 

Justin Girouard  28:22

Right

 

Mark Young  28:23

But after that, you need to leave them to be independent if you want to have a good clinical trial. And again, none of this means you can make a drug claim.

 

Justin Girouard  28:33

Oh, no, no, no, no, no, in fact, on on that note, what would you say? Because we already. Would you say that it is a must or just a good to have to ensure that you've already consulted with an FDA FTC lawyer prior to?

 

Mark Young  28:57

I would absolutely have an FDA FTC expert lawyer on my team before I even started building my trial.

 

Justin Girouard  29:06

That's a must. There's no question about it.

 

Mark Young  29:08

Because two reasons. One, I would show my attorney my trial, I would show them the questions I'm asking. I would show them my methodology that my research is going to use. And then I would let them review my trial and review it against the claims that I want to make. One is you don't want to go make claims and have the FTC show up on your door because they have really powerful policeability. And they can do things like close you down and seize your bank account and put a padlock on your door. If they want to. They have like IRS kind of power. And as a rule, it's the FTC that's going to come looking for you not the FDA. The difference is the FDA controls drugs. The FTC is responsible for what is said In advertising.

 

Justin Girouard  30:01

Right.

 

Mark Young  30:02

And that's the bigger risk.

 

Justin Girouard  30:04

Of course, always.

 

Mark Young  30:06

So I would have that attorney on staff. The second reason you want to have that attorney is because the FDA and the FTC has rightfully ruled in the past, that if an advertiser has hired a qualified law firm, a law firm that has experts in the FDA and the FTC regulations, and if that law firm writes that client a letter saying, we've reviewed your claims, we've reviewed your comments. And we we find in our opinion that they meet or exceed the guidelines of the FTC. If the lawyer writes you that letter, then as a rule, the FTC says, okay, you had the right to rely on this expert to believe them, you have the right to believe this lawyer, you tried to do the right thing. You spent the money, you did the work. And you're not a lawyer. So you have the right to trust the lawyer's opinion, even if the lawyer was wrong.

 

Justin Girouard  31:08

Right.

 

Mark Young  31:08

You did the right thing, there was no intent on your part to defraud the public.

 

Justin Girouard  31:14

Exactly.

 

Mark Young  31:15

So under that condition, the FDA and the FTC will usually say, Here's a 90 day cease and desist letter. And they will say we no longer want you to say this, and we're giving you 90 days to scrub all of your materials from this comment. So get this off your website, get this off your packaging, get this off your TV commercial, whatever the case is, get rid of this, we're not going to do anything bad to you. Because we feel you attempted to do the right thing.

 

Justin Girouard  31:44

Right.

 

Mark Young  31:45

And we're not going to punish you for doing the right thing.

 

Justin Girouard  31:48

Right. Absolutely.

 

Mark Young  31:50

Without the lawyers letter. You are now deciding that you are an expert in the FDA and the FTC. And the FDA, the FTC is now going to hold you to the standard of you are you are an expert in this field. Therefore, you have no plausible deniability anymore. You are you have decided you are an expert. Right? You are for whatever it costs to get that lawyer and it's not that much. You are so far ahead of the game. To have that layer of plausible deniability to say look, FTC look, I have a letter here from my from my law firm, saying that they thought we were in compliance. And it should this ever happened to you that letter will be the most monumentous wonderful thing you have ever spent $2,000 on or even $5,000 on in your entire career. Yep, exact now, the last thing I'm gonna leave before we wrap up here just and I'm gonna give people another little secret. This is one of our agency secrets is is actually a real secret sauce secret.

 

Justin Girouard  33:01

Oh, come on Mark, you can't be give away our secrets.

 

Mark Young  33:04

Sometimes people come to us with a great formula. And it's got five different supplements in it or whatever the case is. And guess what? It works. It's great. It lowers blood pressure, it relieves pain, it gets rid of wrinkles, it helps you not you know want to eat it lowers A1C it lowers blood glucose. But what it does is it makes a drug like claim. So what we will do is we will sometimes start researching what drug has a monograph that actually can make that claim. And what is the smallest what is called the minimum dose? What is what is the it's actually called minimum effective dose MED? What is the minimum effective dose of this particular drug? Could I add it to my formula? And of course, I need to do the work to find out does my formula have any detrimental effect on the drug and does the drug have any detrimental effect on my formula? So now what I ended up doing, I ended up saying that I have this secret sauce that relieves arthritis pain. I put in a drug that is at the at the lowest possible dosage where I can use the indication. I now call all my other ingredients inactives on the label, even though I know that the inactives are really the actives. And here's it is in a nutshell, in the world of the FDA and the FTC. Only drugs can make a claim about a disease. Again, in their world, a supplement or a nutraceutical cannot make a disease claim, because it can only make a claim to assist the body in a process. So we're aspirin relieves a headache. I can't say that a particular supplement relieves headaches, because that's a drug claim, even if it does. And I will tell you, there are many supplements on the market that have direct drug like effects on the human body. But without a FDA clinical trial and a monograph in the world of the federal government, they don't exist. The third level, so you have drug, you have supplement and vitamin, then the third level is called cosmetic. Cosmetic is, my face cream reduces the appearance of fine lines. By face cream or my body lotion reduces the look of bruising it, it reduces the appearance of crepey skin, it appears to make skin feel softer, and more supple, whatever my claim is, those are cosmetic claims. And in the world of cosmetic claims, we're making appearance statements. So this makes your hair shinier, this makes your hair look healthier this, whatever the case is. These are cosmetic. Oh, by the way, when you're looking into this, I'm going to tell people just start grabbing stuff around your house. And you'll be surprised how many things actually have drug monographs. So like grab a bottle of head and shoulders. Head and shoulders as a drug monograph in it.

 

Justin Girouard  36:49

Yeah.

 

Mark Young  36:51

Because it has a drug in it.

 

Justin Girouard  36:52

Right.

 

Mark Young  36:54

A lot of this stuff has drugs added to it. And I can tell you that we have helped clients take products that work amazingly well added a tiny amount of a drug that did nothing. But bring the claim. And now we can make the claim.

 

Justin Girouard  37:09

Exactly.

 

Mark Young  37:10

So there's a lot to this, these are areas that you know that we've been guiding people around for years. Again, I will tell you, we're not a law firm, or an advertising agency. But we can help guide you with it. And we can direct you to law firms that can help you navigate this.

 

Justin Girouard  37:30

Exactly.

 

Mark Young  37:32

I think we've pretty much covered everything on this any last thoughts that you can think of Justin?

 

Justin Girouard  37:36

No, no, no. I mean, I think we really covered it. I said there's multiple options in this space. But again, start with what is it that you're trying to say? What is the question you're trying to answer? And then truly, truly reach out to advisors reached out to a firm like ours that can guide you and assist you in and understanding what the question should be? What are the what are the things we're trying to say? So you really get good direction, make sure that you get that FTC, FDA lawyer on staff ready to go before you make any steps. Because again, as Mark stated, it could just be as simple reformulation. And I mean, I'd say the word simple, right. But the reformulation may be really what you need to do. And it might be the path of least resistance to get to where you want to go, as opposed to trying to go for a full clinical, but then understanding what is the right type of clinical to get to where you want to go? Because again, we've got the biological, we've got observational, and all that comes around to what is it that I'm trying to say? Do we believe that an observational claim is strong enough for my product? For my right, there's a lot of things that you need to do, pre to even thinking about something like this, and don't do it alone. That is the best thing I think we can tell you is do not do this alone.

 

Mark Young  38:57

Yeah. And let me give an example. As long as we've been doing this. I have different coaches in my life that helped me along the way. One of my coaches, my business coaches, a guy by the name Dan Sullivan. He's one of the top coaches in the world. And Dan has come to coach Strategic Coach. Well, Dan wrote a book recently that's become a best seller. And the book is called Who not How. And it's a brilliantly simple concept. And what Dan has been able to do through his work is show that the companies that survive the people who have the tremendous successes are not the people who know how to do everything. They're the people who know who can do everything. Because none of us can know everything, it's not possible. So think about Who not How I don't need to know how to do a clinical trial. I need to know who to call, who can guide me through A clinical trial. I don't need to know how to run an ad campaign, I need to know who can run an ad campaign, who are the who's in your life. And that's the key to success, finding and collecting the right group of who's that can do the hows.

 

Justin Girouard  40:19

Exactly.

 

Mark Young  40:20

And by the way, I would recommend the book to people. It's Dan Sullivan. And the book is called, Who not How and I think Matt's gonna put a link to the book in the show notes.

 

Justin Girouard  40:29

Yep. It's a great book.

 

Mark Young  40:31

Well, I think that wraps us up for today. And as Justin said earlier, if you have a show topic you'd like to see answered, just reach out to us, you can get a hold of us at JekyllHydelabs.com. Or you can get a hold of us at CPGinsiders.com. And, Matt, have put links right in the show notes where you can get to us or email us. And again, if your business has any of these questions, reach out to us. And we can set up a meeting with either one of us at some point, we're pretty backed up. And sometimes it takes a week or two to get a meeting. But we're happy to to set up a an exploratory phone call and listen to your questions and give you the best advice we can give you that doesn't cost you any money to have a chat with us. It just might take a little bit to get a time set up.

 

Justin Girouard  41:18

Absolutely. Yep, absolutely.

 

Mark Young  41:20

Well, that's it for today, and we'll see you on the next episode of CPG insiders. If you're looking to greatly increase sales on your CPG product, don't hesitate to contact us at Jekyll and Hyde advertising and marketing. By the way, the only advertising agency with a guaranteed result just go to JekyllHydeagency.com Or feel free to give us a call at 800-500-4210